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| Statement |
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| This device is complementary to SeaStar's medical Quelimmune, and we believe these 2 products will add tremendous value to our growing portfolio of products with pediatric patients with fluid overload and renal disease |
| We, along with many pediatric nephrologists, believe this product will have extremely positive impact on survival and significantly improve the lives of neonates and small children with kidney malfunction kidney issues or those born without kidneys |
| The addition of this product to our growing pediatric customer category will help save lives of many pediatric patients and further bolster our top line growth |
| As I mentioned before, we're very excited about the 2024 |
| Hospitals navigated budget limitations by utilizing our rental programs resulting in a 23% year-over-year revenue growth, highlighting the flexibility and affordability that we offer |
| This signifies strong potential for future utilization growth |
| While our overall growth might seem modest at 4%, we had a very strong second half of the year, resulting in a 27% revenue growth compared to the first half of the year |
| In the fourth quarter of 2023 Nuwellis has generated $2.6 million in revenue, a 9% increase versus the fourth quarter of 2022, led by an increase in disposable utilization and record quarterly international sales |
| And also the steady progress on our product pipeline with our new pediatric dedicated CRRT device, branded Vivien |
| I'm pleased to report that we ended 2023 on a high note, recording our highest total quarter revenue in the company history |
| In the fourth quarter, our pediatric customer category once again led the way with 35% growth over the prior year driven by a 28% increase in utilization and a 49% increase in console sales, and we opened 4 new pediatric accounts |
| With our steadfast focus on executing on our strategic growth initiatives, positive momentum in our business continues to build |
| Our pediatric customer category had the strongest growth in Q4 with a 35% increase year-over-year |
| Overall, we continue to drive utilization gains and opening new accounts which reflects continued increase in the number of patients being treated with the Aquadex therapy on an expanding console footprint |
| This follows a similarly strong third quarter, which saw a 16% growth over Q2 2023 |
| We also remain encouraged by our own internal product development program as we continue to advance development of our pediatric continuous kidney replacement therapy device branded as Vivian |
| Revenue for the fourth quarter was $2.6 million, representing 9% year-over-year growth and a 6% sequential increase from the third quarter of 2023 |
| These 3 presentations further reinforced the efficacy of ultrafiltration reestablishing Aquadex as the preferred method of treating congestion in patients with fluid overload resistant to diuretics |
| 2024 is poised to be another important year for us with key value milestones targeted |
| The introduction of these new asset catheters should be well received with clinicians firming to us the need for this product |
| The pediatric customer category led with an 11% increase in utilization followed by critical care with a 9% increase in utilization |
| This new 12-centimeter dELC has the same features as the longer 16-centimeter option but eliminates the need for trimming when a shorter catheter is needed, ultimately, leading to increased patient comfort |
| However, we saw a remarkable turnaround in the second half with domestic console sales skyrocketing 207% compared to the first half |
| We are pleased to continue to expand our clinical evidence, including a symposium yesterday at THT on the clinical merits of Aquadex for a growing number of patients |
| We -- that's a very good point, Anthony |
| Despite the nursing staff shortages, the number of patients treated with Aquadex therapy increased by 9% from the first half of 2023 to the second half of 2023, demonstrating the value of our therapy provides |
| In early January of this year, we were pleased to announce that received FDA clearance for an additional dual lumen extended length peripheral catheter also called dELC |
| This study demonstrates a new application for the Aquadex system for a large and growing patient population with end-stage liver disease |
| For the full year 2023, Newells generated revenue of $8.9 million, a 4% increase versus full year 2022 |
| On February 22, we were pleased to announce that our strategic collaborator, SeaStar Medical, received the Humanitarian Device Exemption or HDE from the FDA for its selective cyokine cytoperetic device also called SCD, branded Quelimmune for use in pediatric acute kidney injury patients |
| Statement |
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| Total sales decreased -- total console sales, excuse me, decreased by 21% and for the year because of the industry headwinds we faced in the first half of the year |
| Our capital equipment sales faced industry-wide headwinds in the first half of the year |
| Heart failure and critical care sales declined 27% and 7%, respectively |
| The margin decline is primarily driven by product and geographical sales mix and lower fixed overhead manufacturing absorption, leading to more efficient inventory levels |
| Operating loss in the fourth quarter was $3.6 million compared to an operating loss of $4.5 million in the prior year period, resulting in a $941,000 period-over-period reduction |
| We had a couple of accounts that were just a little bit soft in Q3, just a handful of them |
| For clinicians treating patients with end-stage liver disease, it can be an enormous challenge to remove fluid when patients don't respond or can't tolerate diuretic therapy safely and effectively |
| Heart failure was relatively flat, posting a 1% decline in utilization |
| I want to thank all our stakeholders, including our employees, stockholders, medical staff, visions and health care workers without your help, we will not be able to achieve the transformation in the lives of patients suffering from fluid overload |
| Heart Failure and Critical Care decreased 27% and 7%, respectively |
| again, from dollars perspective, it was about $160,000 decline |
| Net loss attributable to common shareholders in the fourth quarter was $7.9 million or a loss of $2.24 per share compared to a net loss attributable to common shareholders of $1.9 million or $5 per share for the same period in 2022 |
| Total operating expenses were $5 million in the quarter, a decrease of approximately $884,000 as compared to the fourth quarter of 2022 |
| Selling, general and administrative expenses were $3.6 million in the fourth quarter, a decrease of 23% as compared to $4.7 million in the fourth quarter of 2022 |
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